First Birth Control Pill Shown Effective for Premenstrual Dysphoric Disorder

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Oct. 6, 2006 -- Yaz has become the first birth control pill to gain FDA
approval for treating premenstrual dysphoric disorder (PMDD), the most severe
form of PMS.

The FDA based its action on clinical trial results showing that Yaz cut PMDD
symptoms by at least half. Women taking Yaz reported twice as much improvement
in PMDD symptoms as women taking inactive placebo pills.

Yaz improved both physical and emotional symptoms of PMDD, including
interpersonal relationships, work productivity, and enjoyment of hobbies and
social activities.

Like other birth control pills, Yaz uses the female hormones estrogen and
progestin. Unlike other versions of the pill, Yaz uses a form of progestin that
has unique properties. This, plus its 24-day dosing regimen, may help account
for its positive effect on PMDD, says Andrea Rapkin, MD, in a news release from
Berlex Inc., the U.S. affiliate of Schering that manufactures Yaz.

"For my PMDD patients who need a treatment to reduce their symptoms -- as
well as a safe and effective contraceptioncontraception to prevent pregnancypregnancy -- YAZ is an important option that can
meet both of their health care needs in a single pill," says Rapkin, professor
of obstetrics and gynecology at UCLA's David Geffen School of Medicine.

While most women have some PMS symptoms, PMDD occurs when these symptoms are
at their most severe. PMDD affects about 5% of women.

PMDD: PMS Squared

Think of PMDD as PMS squared. Women with PMDD have at least five severe
premenstrual symptoms. These may include:

At least one of the first four symptoms must be present for a diagnosis of
PMDD. The symptoms occur during the week before a woman's period and resolve
within a few days after her period starts.

Because PMDD is so severe, doctors usually prescribe antidepressants,
antianxiety medications, hormonal treatments, and/or water pills. While doctors
have used other oral contraceptives as treatments for PMDD, Yaz is the first
drug of this class to receive specific FDA approval for this purpose.

The most common side effects seen in women taking Yaz are headache and
breast pain.